INTRODUCTION: In CheckMate 227 (NCT02477826), patients with treatment-naive stage IV/recurrent non-small cell lung cancer (NSCLC) and tumor programmed death ligand 1 (PD-L1) expression ≥ 1% demonstrated significantly improved overall survival with nivolumab plus ipilimumab versus chemotherapy. We present patient-reported outcomes (PROs). METHODS: Patients (N = 1189) were randomized to nivolumab plus ipilimumab, nivolumab, or chemotherapy. PROs were exploratory. Changes in Lung Cancer Symptom Scale (LCSS) average symptom burden index (ASBI), LCSS 3-item global index (3-IGI), EQ-5D visual analog scale (VAS), and EQ-5D utility index (UI) were analyzed descriptively. Mixed-effect model repeated measures (MMRM) and time to first deterioration/improvement (TTD/TTI) analyses were conducted. RESULTS: PRO completion rates were generally > 80%. On-treatment improvements from baseline in LCSS measures of symptom burden and global health status with nivolumab plus ipilimumab generally met or exceeded the minimal important difference (MID; smallest clinically meaningful change) from weeks 24 and 30, respectively; improvements with chemotherapy generally remained below the MID. Mean on-treatment EQ-5D VAS scores for both treatments approached the UK population norm at week 24, remaining so throughout the treatment period. MMRM analyses showed numerically greater improvements from baseline with nivolumab plus ipilimumab versus chemotherapy across LCSS ASBI/3-IGI and EQ-5D VAS/UI. Nivolumab plus ipilimumab had delayed TTD (hazard ratio [95% confidence interval] 0.74 [0.56-0.98]) and a trend for more rapid TTI (1.24 [0.98-1.59]) versus chemotherapy. CONCLUSION: Nivolumab plus ipilimumab demonstrated delayed deterioration and numerical improvement in symptoms and health-related quality of life versus chemotherapy in patients with advanced NSCLC and PD-L1 expression ≥ 1%.
- Reck, M.
- Ciuleanu, T. E.
- Lee, J. S.
- Schenker, M.
- Audigier-Valette, C.
- Zurawski, B.
- Linardou, H.
- Otterson, G. A.
- Salman, P.
- Nishio, M.
- de la Mora Jimenez, E.
- Lesniewski-Kmak, K.
- Albert, I.
- Ahmed, S.
- Syrigos, K.
- Penrod, J. R.
- Yuan, Y.
- Blum, S. I.
- Nathan, F. E.
- Sun, X.
- Moreno-Koehler, A.
- Taylor, F.
- O'Byrne, K. J.
